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Superiority of multilevel cervical arthroplasty outcomes versus single-level outcomes: 229 consecutive PCM prostheses.

机译:多级颈椎置换术结果优于单级结果:229个连续PCM假体。

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STUDY DESIGN/SETTING: Class 2 level of evidence: This is a prospective, consecutive series of 229 prosthetic implantations that were concurrently enrolled between single-level versus multilevel cervical arthroplasty comprising an FDA Pilot Study. OBJECTIVE: This study investigated multilevel cervical disc replacement in relation to single-level cervical arthroplasty to find if the same reduction in clinical success would occur with this alternative treatment. SUMMARY OF BACKGROUND DATA: Usually, the clinical outcomes of instrumented cervical fusions deteriorate as the number of vertebral levels of involvement increases. METHODS: A total of 229 patients presented with cervical herniated nucleus pulposus, cervical spondylosis, and/or adjacent segment disease with cervical radiculopathy or myelopathy. Following anterior cervical neurologic decompression seventy-one patients required porous coated motion (PCM) cervical arthroplasties from C3-C4 to C7-T1 (Group S, single level). Sixty-nine patients underwent 158 multilevel PCM cervical arthroplasties (Group M, multilevel) during the same time interval, for the same indications, performed by the same surgeons under the same clinical protocol: double level, 53 cases; three levels, 12 cases: and 4 levels, 4 cases. RESULTS: The self-assessment outcomes instruments showed significantly more improvement for the multilevel cases. The mean improvement in the NDI for the single cases was 37.6% versus the multilevel cases mean improvement in NDI was 52.6% (P = 0.021). The difference between the two was statistically significant. The mean improvement in the VAS showed the same association: single-level mean improvement 58.4% versus the multilevel cases mean VAS improvement was 65.9%. The Odom's were also more improved for the multilevel versus the single-level group: 93.9% versus 90.5% in the excellent, good, and fair categories. The reoperation rates and serious adverse events were similar between the single-level (S = 3) to the multilevel arthroplasty (M = 2) groups. Kaplan-Meier implant survivorship analysis at 3 years for the cohort of 229 prostheses was 94.5% (confidence interval, 1.00-0.820). CONCLUSIONS: This prospective study of cervical arthroplasty is the first report to date showing significantly improved clinical outcomes for multilevel cervical arthroplasty compared with single-level cervical disc replacement using an FDA validated outcome instrument.
机译:研究设计/设置:2级证据:这是前瞻性,连续性的229例假体植入系列研究,同时纳入了FDA试点研究的单级与多级颈椎置换术之间。目的:本研究调查了与单级颈椎置换术相关的多级颈椎间盘置换术,以发现这种替代疗法是否会导致相同的临床成功率下降。背景技术摘要:通常,随着累及椎骨水平的增加,器械式颈椎融合器的临床疗效会恶化。方法:共有229例患者出现颈椎椎间盘突出症,颈椎病和/或邻近节段性疾病,并伴有颈椎神经根病或脊髓病。颈椎前路神经减压后,有71名患者需要从C3-C4到C7-T1进行多孔包膜运动(PCM)颈椎置换术(S组,单级)。 69名患者在相同的时间间隔,相同的适应症,相同的外科医生根据相同的临床方案进行了158次多级PCM颈椎置换术(M组,多级);双级53例;双级。三个级别12例:和4个级别4例。结果:自我评估结果工具显示出多级病例的明显改善。单例患者的NDI平均改善为37.6%,而多级病例的NDI平均改善为52.6%(P = 0.021)。两者之间的差异具有统计学意义。 VAS的平均改善显示出相同的关联:单级平均改善58.4%,而多级病例平均VAS改善为65.9%。与单级组相比,多级组的Odom评分也有所提高:优秀,良好和公平组的93.9%比90.5%。单级(S = 3)组和多级(M = 2)组之间的再手术率和严重不良事件相似。 229个假体队列在3年时的Kaplan-Meier种植体存活率分析为94.5%(置信区间为1.00-0.820)。结论:这项前瞻性的颈椎置换术研究是迄今为止的第一份报告,显示与使用FDA验证的结局工具进行单层颈椎间盘置换术相比,多层颈椎置换术的临床疗效显着改善。

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